File a New Federalwide Assurance (FWA)

File a New Federalwide Assurance (FWA)

Institutions must submit all FWAs, including new FWAs, electronically using the electronic submission system available through the OHRP website at http://ohrp.cit.nih.gov/efile/, unless an institution lacks the ability to do so electronically.  If an institution believes it lacks the ability to submit its FWA electronically, it must contact OHRP by telephone or email (see http://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/contact/index.html) and explain why it was unable to submit its FWA electronically.

The institution must update its FWA within 90 days after changes occur regarding the legal name of the institution, the Human Protections Administrator, or the Signatory Official.  The FWA is effective for 5 years and must be renewed every 5 years, even if no changes have occurred, in order to maintain an active FWA.  Any renewal or update that is submitted electronically, and approved by OHRP, begins a new-5-year effective period.

Obtaining a submission number is the first step to file a new FWA.

  1. Go to the site: http://ohrp.cit.nih.gov/efile/FwaStart.aspx
  2. Scroll down to the bottom of the screen and click on ‘I need a submission number”
  3. Enter
    1. Your e-mail
    2. a password created for the submission, and
    3. a password hint that cannot be the same as the password.
  4. Click on the “Submit” button
  5. Once you receive the submission number:
    1. Repeat step 1 above.
    2. Then scroll down to the bottom of the screen and click “I have a submission number”.
    3. Enter the submission number and the password
    4. Click on the “Submit” button
    5. The FWA fields will be presented to complete

If an Institution lacks the ability to submit its FWA electronically, after consulting with OHRP, it must send the FWA application to OHRP in writing, by: FAX (240-453-6909; email (IRBorFWA@hhs.gov); or mail (Division of Policy and Assurances, Office for Human Research Protections, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852).

The FWA application form, terms of FWA and instructions can be accessed at: http://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/forms/index.html

Frequently Asked Questions (FAQs) on the Assurance Process can be accessed at: http://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/assurance-process-faq/index.html.

A short tutorial on the Assurance process can be accessed at: https://youtu.be/N-MmuqHJOnE

Content created by Office for Human Research Protections (OHRP)
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